Working… Menu

Sphenopalatine Ganglion Blocks RCT (SPGblock)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03666663
Recruitment Status : Active, not recruiting
First Posted : September 12, 2018
Last Update Posted : July 7, 2021
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
RCT of Sphenopalatine Ganglion (SPG) Blocks using anesthetics vs. placebo for migraine.

Condition or disease Intervention/treatment Phase
Migraine Drug: Lidocaine Drug: Bupivacaine Drug: Ropivacaine Drug: Placebo Phase 4

Detailed Description:

Chronic Migraine is a brain disorder with high prevalence. It is the 7th leading cause of disability worldwide according the WHO.

SPG block is a treatment for migraine that has been used for two decades. It can be done by needle injection of anesthetic to the region of the SPG. However, there are now multiple catheter devices that can be used to non-invasively administer anesthetic topically through the nasal cavity to the region of the SPG where the anesthetic is then absorbed through thin membranes covering the SPG.

Various anesthetic agents have been studied however currently, to our knowledge, there is no head to head comparison of the various anesthetics used. Studies of SPG blocks in the setting of chronic migraine are few as compared to the use of SPG as acute treatment for migraine.

With the use of an RCT, we aim to determine the overall efficacy of SPG blocks used at longer intervals than have been studied in the past as compared to placebo, as well as to examine the relative efficacy of the anesthetics used most commonly and studied for SPG blocks.

We will be using an FDA cleared device, the Sphenocath which was developed and registered with the FDA for this specific population and purpose. The study intervention is the standard practice in the UCSF Headache Center to perform SPG blocks for our patients with chronic migraine. The frequency we use in clinical practice and that we plan to study is less often than in previous studies of this intervention in this population.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized placebo controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind study
Primary Purpose: Treatment
Official Title: UCSF Sphenopalatine Ganglion Block Study- a Randomized Double Blind Placebo Controlled Trial to Compare Nasal Anesthetics for Migraine Prevention in Adults.
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Lidocaine
Participants will receive SPG blocks with lidocaine.
Drug: Lidocaine
Nasal application using the Sphenocath device- cleared by FDA

Experimental: Bupivacaine
Participants will receive SPG blocks with bupivacaine
Drug: Bupivacaine
Nasal application using the Sphenocath device- cleared by FDA

Experimental: Ropivacaine
Participants will receive SPG blocks with ropivacaine
Drug: Ropivacaine
Nasal application using the Sphenocath device- cleared by FDA

Placebo Comparator: Placebo (saline)
Participants will receive SPG blocks with placebo (saline)
Drug: Placebo
Placebo Saline using the Sphenocath device- cleared by FDA
Other Name: Placebo Saline

Primary Outcome Measures :
  1. Reduction in headache days [ Time Frame: 8 months ]
    Reduction in headache days from baseline to month 8 of treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18 years or more at time of consent
  2. Current patients in the UCSF Headache Center eligible to receive SPG blocks for migraine and would otherwise receive treatment clinically
  3. Ability to provide consent for the research study

Exclusion Criteria

  1. Pregnant or breast feeding within 4 weeks of enrollment
  2. Inability to communicate with the study team
  3. Patients who cannot read and understand English
  4. Deemed unsuitable for enrollment in study by the investigator
  5. Allergy to local anesthetics or saline

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03666663

Layout table for location information
United States, California
UCSF Headache Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Layout table for investigator information
Principal Investigator: Nina Riggins, MD UCSF Headache Center

Layout table for additonal information
Responsible Party: University of California, San Francisco Identifier: NCT03666663    
Other Study ID Numbers: 18-25736_SPG_2018.09
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action